Treatment of Chronic Laryngitis With Amitriptyline

NCT ID: NCT02552225

Last Updated: 2021-10-29

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE2/PHASE3
• Total Enrollment: 6 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-04-30
• Study Completion Date: 2021-01-15

Brief Summary

This randomized, double-blind, placebo-controlled trial will compare the effectiveness of amitriptyline versus placebo (inactive medication) in treating chronic laryngitis.

Detailed Description

Chronic laryngitis commonly manifests through symptoms including cough, hoarseness, throat clearing, foreign body sensation, throat pain, sensation of excessive phlegm, and difficulty swallowing. A significant minority also present with GERD, rhinosinusitis-induced post-nasal drainage, direct allergic effect, and smoking issues.

Amitriptyline is commonly used for mental/mood problems, but is also prescribed to treat chronic laryngitis because some investigators suggest a neuropathic etiology for idiopathic chronic laryngitis. No trials have compared any treatment for chronic laryngitis to placebo and it is unknown if currently used therapies for chronic laryngitis are effective.

At the baseline visit, subjects will be assigned at random to amitriptyline or placebo, which they will take for 4 weeks each. Subjects will be seen in the clinic at baseline and after 10 weeks. Improvement will be measured using standardized symptom scales, and a self-reported subjective improvement percentage.

Conditions

Laryngeal Diseases

Keywords

laryngeal sensory neuropathy, chronic laryngeal neuropathy

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

amitriptyline

Subjects in this arm will receive pills composed of amitriptyline and Avicel (cellulose filler)

Group Type: EXPERIMENTAL

Amitriptyline

Intervention Type: DRUG

Subjects in this arm will receive pills composed of amitriptyline and Avicel (cellulose filler)

placebo

Subjects in this arm will receive pills composed only of Avicel (cellulose filler)

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: OTHER

Subjects in this arm will receive pills composed only of Avicel (cellulose filler)

Interventions

Amitriptyline

Subjects in this arm will receive pills composed of amitriptyline and Avicel (cellulose filler)

Intervention Type: DRUG

Placebo

Subjects in this arm will receive pills composed only of Avicel (cellulose filler)

Intervention Type: OTHER

Other Intervention Names

Elavil

Eligibility Criteria

Inclusion Criteria

1. Must be age 18 or older and able to consent for themselves

2. Must have had structural pathology such as tumor previously ruled out using flexible laryngoscopy

3. Must be able to speak and read the English language

4. Must have failed a 2 month or longer trial of a proton pump inhibitor for the treatment of gastro-esophageal reflux

5. Women under 55 years of age who may become pregnant must have a negative pregnancy test and agree to barrier or hormonal methods of contraception during the study

6. Potential subject and their physician have agreed that amitriptyline will be part of their regular care plan

Exclusion Criteria

1. Active untreated environmental allergies

2. Smoking within past 5 years

3. Current upper respiratory infections

4. Use of narcotics (e.g. oxycodone, methadone) within the past week

5. Hypersensitivity to amitriptyline

6. History of amitriptyline use or of other tricyclic antidepressant - including pregabalin, gabapentin, baclofen, or other gamma-aminobutyric acid (GABA)analogues or inhibitors - for any medical condition (not limited to chronic laryngitis) within the past 12 months.

7. Use of any other monoamine oxidase inhibitors (MAOIs) other than amitriptyline within the past 4 weeks (selegiline, phenelzine, tranylcypromine, isocarboxazid, rasagiline, phenelzine sulfate, selegiline hydrochloride, rasagiline mesylate, tranylcypromine sulfate)

8. History of urinary retention

9. History of an acute episode of a major depressive disorder within the past 12 months

10. For women 18-55 years of age without history of menopause: currently nursing or pregnant, plans to become pregnant, or unwillingness to utilize contraception (barrier or hormonal methods)

11. Currently participating in another clinical trial that could interfere with the efficacy of, or participation in, this study.

12. Current untreated diagnosis of gastroesophageal reflux (GERD)

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Boston Medical Center

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

J. Pieter Noordzij, MD

Role: PRINCIPAL_INVESTIGATOR

Boston Medical Center

Locations

Boston Medical Center

Boston, Massachusetts, United States

Countries

United States

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

H 34438

Identifier Type: -

Identifier Source: org_study_id